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A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year (COBALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143479
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma S.A.S. )

Study Description
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Brief Summary:
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.

Condition or disease Intervention/treatment
Liver Transplantation Drug: Tacrolimus

Study Design
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Study Type : Observational
Actual Enrollment : 398 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study
Actual Study Start Date : June 18, 2014
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : May 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Groups and Cohorts
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Group/Cohort Intervention/treatment
1:early conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® in the first 3 months after transplantation
 Drug: Tacrolimus
oral
Other Names:
  • FK506
  • Prograf
  • Advagraf
2:late conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation
 Drug: Tacrolimus
oral
Other Names:
  • FK506
  • Prograf
  • Advagraf


Outcome Measures
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Primary Outcome Measures :
  1. Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®) [ Time Frame: At baseline ]
    Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg

  2. Time of the first tacrolimus trough level (C0) after conversion [ Time Frame: From baseline to first determination of C0 (up to 6 months) ]
    Number of days between the conversion date and the date of the first determination of C0 after conversion

  3. Number of additional visits considered by the physicians to be due to the conversion (if required) [ Time Frame: At 6 months and at 1 year follow-up visit ]
    Percentage of patients with additional visit(s) and percentage of patients without an additional visit


Secondary Outcome Measures :
  1. Reasons for conversion [ Time Frame: At baseline ]
    Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice

  2. Patient profile [ Time Frame: At baseline ]
    Sociodemographic data, history of transplantation, comorbidities, complications after transplantation, risk factors, concomitant treatments (other than immunosuppressive protocols) and modification, if required, at 6 months and 1 year after conversion

  3. Collection of immunosuppressive protocol details [ Time Frame: At baseline, 6 months and 1 year follow-up visit ]
    • Date of initiation of treatment with Advagraf®
    • Target tacrolimus C0 (with Prograf® and with Advagraf® and recommendations for administration)
    • Daily dose of Advagraf®
    • Adjustments to Advagraf® dose since the previous visit: date, doses and reason for adjustment
    • Type and dose of immunosuppressive drugs combined with Advagraf®
    • Modification of the immunosuppressive regimen at 6 months and 1 year after conversion (if applicable) since the previous visit: date, modified treatment, type of modification, reason for modification
    • Immunosuppressive regimen at the end of the visit at 6 months and 1 year after conversion, modified treatment, type of modification, reason for modification

  4. Time to reach steady state [ Time Frame: From baseline to first determination of C0 (up to 6 months) ]
  5. Dose ratio at steady state [ Time Frame: From baseline and up to 6 months post-conversion ]
    Ratio of daily dose of tacrolimus during achievement of steady state: mg Prograf® at conversion/mg Advagraf® during achievement of steady state. Percentage of patients with a ratio of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg

  6. The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ® [ Time Frame: At baseline (Prograf) and during the 45 days after conversion (Advagraf) ]
  7. Latest available laboratory data with Prograf® before conversion and with Advagraf® [ Time Frame: At baseline, 6 months and 1 year follow-up visit ]
    Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load

  8. Compliance with treatment at conversion [ Time Frame: At baseline and at 1 year after conversion ]
    Compliance with treatment at conversion (with Prograf® and only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the Morisky questionnaire and a score will be calculated

  9. Patients' quality of life at conversion [ Time Frame: At baseline and at 1 year after conversion ]
    Patients' quality of life at conversion (with Prograf® only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the European Quality of Life-5 Dimensions 5 level (EQ5D-5L) questionnaire

  10. Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate [ Time Frame: 6 months and 1 year ]
    Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions

  11. Occurrence of adverse events and/or effects [ Time Frame: From baseline until 1 year follow-up visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Liver transplant patients
Criteria

Inclusion Criteria:

  • Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.

Exclusion Criteria:

  • Patient participating in an interventional clinical trial at the time of enrolment into the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143479


Locations
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France
Site
Besancon, France
Site
Bordeaux, France
Site
Caen, France
Site
Chambray les Tours, France
Site
Clichy, France
Site
Creteil, France
Site
Grenoble, France
Site
Lille, France
Site
Limoges, France
Site
Lyon 3, France
Site
Lyon 4, France
Site
Marseille, France
Site
Montpellier, France
Site
Nice, France
Site
Paris, France
Site
Rennes, France
Site
Toulouse, France
Site
Villejuif, France
Sponsors and Collaborators
Astellas Pharma S.A.S.
Investigators
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Study Director: Medical and Scientific Affairs Manager, Transplantation Astellas Pharma S.A.S.
More Information
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Responsible Party: Astellas Pharma S.A.S.
ClinicalTrials.gov Identifier: NCT02143479    
Other Study ID Numbers: FR-ADV-NI-002
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma S.A.S. ):
France
Prograf
Pharmaco-epidemiology
Tacrolimus
Observational
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action